Breath Delivery System and Method

ABSTRACT

Some embodiments of the invention provide a mouthpiece for use with an electronic analyzer for breath analyte detection in an individual. The mouthpiece includes a biosensor and a hydration system. The biosensor includes a chemically active area where a chemical reaction takes place and the hydration system delivers a liquid to the chemically active area of the biosensor to at least one of enhance, enable, and facilitate the chemical reaction. The mouthpiece further includes hardware to transmit breath analyte data.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/001,172 filed on Oct. 31, 2007. The entire disclosure of the priorapplication is considered part of the accompanying application and ishereby incorporated therein by reference.

BACKGROUND

Current state of the art mouthpieces for drag delivery use liquids ininhalant and nebulizer mouthpieces in order to deliver therapeutic drugsto a user. However, these mouthpieces are only used for drug delivery(i.e., inhaling contents delivered by the mouthpiece) and therefore donot incorporate any type of sensing systems for vapor analysis (e.g.,analyzing breath contents exhaled through the mouthpiece).

Some conventional mouthpieces used for vapor analysis (e.g., breathanalyte analysis) use a particular breath collection method thatrequires multiple components. For example, a user exhales into themouthpiece, a condenser removes breath moisture, and an attachedcontainer is used to trap a final breath sample. An analyte biosensor isused for subsequent analyte analysis. The analyte biosensor is eitherlocated within the attached container or in a separate piece of analysisequipment that obtains a breath sample from the container. The analytebiosensor chemically reacts with the one or more analytes in the breathsample. The presence of a reaction signifies the presence of thespecific analytes, and the strength of the reaction can signify theamount of analyte in the breath sample. The amount of moisture removedfrom the condenser can be inconsistent and variations due to differentmammalian moisture content in the breath can alter the speed and/orstrength of the reaction on the analyte biosensor. As none of thesemouthpieces incorporate any type of hydration system to create anenvironment with consistent moisture content for each reaction, resultsmay be inaccurate.

SUMMARY

Some embodiments of the invention provide a mouthpiece for use with anelectronic analyzer for breath analyte detection in an individual. Themouthpiece includes a biosensor that detects breath analytes and ahydration system. The biosensor includes a chemically active area wherea chemical reaction takes place. The hydration system delivers a liquidto the chemically active area of the biosensor to at least one ofenhance, enable, and facilitate the chemical reaction. The mouthpiecefurther includes an additional sensor capable of detecting additionalparameters and hardware to transmit breath analyte data and theadditional parameters.

Some embodiments of the invention provide a mouthpiece that includes abiosensor. The biosensor includes a chemically active area where achemical reaction lakes place and is capable of detecting analytes in atleast one of breath, saliva, urine, eye vapor, milk and blood. Themouthpiece also includes a hydration system providing liquid to thechemically active area of the biosensor to at least one of enhance,enable, and facilitate the chemical reaction.

Other aspects of the invention will become apparent by consideration ofthe detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a mouthpiece with an integratedbiosensor according to one embodiment of the invention.

FIG. 2 is a schematic illustration of a mouthpiece with an integratedbiosensor with an integrated manual liquid delivery system according toone embodiment of the invention.

FIG. 3 is a schematic illustration of a mouthpiece with an integratedbiosensor with liquid delivery to the biosensor provided by a fluidtilled sack according to one embodiment of the invention.

FIGS. 4A and 4B are a schematic illustration and a flow chart of asemiautomatic plunger method of hydration according to one embodiment ofthe invention.

FIG. 5 is a schematic illustration of a mouthpiece with an integratedbiosensor with a pump line used to perform liquid delivery to thebiosensor according to one embodiment of the invention.

DETAILED DESCRIPTION

Before any embodiments of the invention are explained in detail, it isto be understood that the invention is not limited in its application tothe details of construction and the arrangement of components set forthin the following description or illustrated in the following drawings.The invention is capable of other embodiments and of being practiced orof being carried out in various ways. Also, it is to be understood thatthe phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items. Unless specified or limited otherwise, theterms “mounted,” “connected,” “supported,” and “coupled” and variationsthereof are used broadly and encompass both direct and indirectmountings, connections, supports, and couplings. Further, “connected”and “coupled” are not restricted to physical or mechanical connectionsor couplings.

The following discussion is presented to enable a person skilled in theart to make and use embodiments of the invention. Various modificationsto the illustrated embodiments will be readily apparent to those skilledin the art, and the generic principles herein can be applied to otherembodiments and applications without departing from embodiments of theinvention. Thus, embodiments of the invention are not intended to belimited to embodiments shown, but are to be accorded the widest scopeconsistent with the principles and features disclosed herein. Thefollowing detailed description is to be read with reference to thefigures, in which like elements in different figures have like referencenumerals. The figures, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope ofembodiments of the invention. Skilled artisans will recognize theexamples provided herein have many useful alternatives and fall withinthe scope of embodiments of the invention.

FIG. 1 illustrates a mouthpiece 10 connected to an electronic analyzer100, according to some embodiments of the invention. The mouthpiece 10can be made of a polymer material, such as polyethylene. The mouthpiece10 can include an integrated biosensor 11, an inlet 12, an outlet 13,and electrical connectors 14. The electrical connectors 14 can connectto an electrical connector receptacle 101 on the electronic analyzer100. The mouthpiece 10 including the integrated biosensor 11 can be usedfor the direct detection of breath analytes. The biosensor 11 caninclude a chemically-active area, such as an area including an enzyme,to permit a chemical reaction when in contact with an analyte. Forexample, the biosensor 11 can be an enzymatic electrochemical breathacetone sensor. As shown in FIG. 1, the biosensor 11 can be integrateddirectly into the mouthpiece 10, therefore removing the need for abreath container. The mouthpiece 10 and/or biosensor 11 can be reusableor disposable. The biosensor 11 can be in the form of a sensor strip.During use, an individual can exhale through the inlet 12, causingbreath gasses to flow directly over the biosensor 11 and out through theoutlet 12. A reaction on the biosensor 11 in response to the breathgasses can lake place directly within the mouthpiece 10. In addition,the electrical connectors 14 can transmit analyte data to the electronicanalyzer 100 in response to the reaction taking place.

The electronic analyzer 100 can include a display 103 and user interface104. The electronic analyzer 100 can be a PDA, cell phone, computer,iPod®, or any device capable of receiving, storing, and/or transmittingdata from the biosensor 11. Alternatively, the electronic analyzer 100can be a sensing device specific to the analyte or analytes beingdetected, such as a breath analyte sensing device for acetone. Invarious embodiments, the mouthpiece 10 can be mechanically orelectrically embedded, or mechanically or electrically integrated intothe electronic analyzer 100. In other embodiments, the mouthpiece 10 caninclude hardware such as a transmitter to transmit data wirelessly to anelectronic analyzer 100.

In some embodiments, the biosensor 11 can require a hydration materialin order to enable, facilitate, and/or enhance the enzymatic reaction.Variations due to different mammalian moisture content in the breath canalter the speed and/or strength of the reaction. To help provideaccurate results with improved precision, the mouthpiece 10 can includean integrated hydration system. The hydration system can provide aconsistent amount of hydration material to the biosensor 11 prior toeach reaction. The hydration material can be water, an acid, a base, aneutral buffer, a hydrogel, a salt solution, or a liquid containingpolymers. The hydration material can depend on the type of biosensor 11.In some embodiments, the viscosity of the hydration material can rangefrom about 0.1 centipoise (cP) to about 200,000 centipoise.

The hydration system can be used to hydrate a dried enzyme on thebiosensor 11. The analyte detected by the biosensor 11 can be some kindof volatile, such as acetone in mammalian breath for fat-burn monitoringor volatile organic compounds (VOCs) for disease or cancer detection.Other volatile-carrying mediums, such as vapor or a gas, can be analyzedusing the biosensor 11 and the hydration system. Some examples includevolatile analyte analysis in animal milk, eye vapor, urine, or mucus.For example, the mouthpiece 10 can act as a chamber containing biosensor11 with the incorporated hydration system over which vapors from theeye, animal milk, blood, or urine is drawn, for example by a pump.

In some embodiments, the actuation of the hydration process can be fullymanual. For example, FIG. 2 illustrates a reservoir-based hydrationsystem. As shown in FIG. 2, a mouthpiece 20 can include a wetting port21. The wetting port 21 can be a small hole in the mouthpiece 20 abovethe biosensor 11. The wetting port 21 can be of a size suitable to allowclearance of a syringe or pipette tip 22. The syringe or pipette 22 canbe used to manually wet the biosensor 11 prior to analysis. In someembodiments, the volume range of hydration material can be about 0.05micro-liters to about 100 micro-liters.

FIG. 3 illustrates a hydration process according to another embodimentof the invention. FIG. 3 illustrates a mouthpiece 30 including afluid-filled sack 31. The sack 31 (also known as a blister pack) can behoused within the mouthpiece 30 near the biosensor 11 or integrated ontothe sensor strip of the biosensor 11. In some embodiments, a pin 32,syringe, or roller can be used to manually pierce or puncture the sack31 to hydrate the active area of the biosensor 11. In other embodiments,a pushbutton (not shown) on the mouthpiece can include a piercing pin topierce the sack 31 when the pushbutton is depressed. In otherembodiments, the pin 32 or roller can be housed within the mouthpiece 30and can be depressed to pierce the sack 31 remotely by the electronicanalyzer 100 or another electronic device to which the mouthpiece 30 iselectrically connected.

FIGS. 4A-4B illustrate a semi-automatic hydration process according toanother embodiment of the invention. FIG. 4A illustrates a mouthpiece 40including a hydration tube 41 and a plunger 42. FIG. 4B illustratesexample method steps for performing the semi-automatic hydration processwith the plunger 42. The mouthpiece 40 can be coupled to the electronicanalyzer 100 by the electrical connectors 14 (task 43). The plunger 42can be coupled to the mouthpiece 40 such that coupling the mouthpiece 40to the electronic analyzer 100 causes the plunger 42 to be depressed(task 44). Once the plunger 42 is depressed, hydration material withinthe hydration tube 41 hydrates the active area of the biosensor 11 (task45). A signal can then be produced by the biosensor 11 based on thechemical reaction with an analyte (task 46). The signal can then betransmitted to the electronic analyzer 100 through the electricalconnectors 14. Finally, data interpreted from the signal can bedisplayed, stored, or transmitted by the electronic analyzer 100 (task47).

In some embodiments, the hydration process can be fully automated sothat hydration occurs with no user intervention. As illustrated in FIG.5, a mouthpiece 50 can have two separate connections to the electronicanalyzer 100, including the electrical connectors 14 and a pump line 51.In addition, the electronic analyzer 100 can include an integrated pump102. The pump line 51 can be coupled to the pump 102. The pump line 41can terminate above, below or at some distance from the active area ofthe biosensor 11. Prior to analysis, the electronic analyzer 100 canautomatically perform the hydration process by supplying liquid from thepump 102 in the electronic analyzer 100 through the pump line 51 tohydrate the active area of the biosensor 11. If the pump line 41terminates below the active area of the biosensor 11, liquid can move tothe active area via wetting. If the pump line 41 terminates somedistance from the active area, liquid can move to the active area viacapillary action. For example, the electronic analyzer 100 can includesome sort of computer program that actuates the hydration process, inwhich pressing a button to begin the analysis starts a timing circuitthat actuates the pump 102 at a set time after the button as beenpressed. Alternatively, a sensor on the mouthpiece 50 can activate thehydration process. In other embodiments, a pump (not shown) can behoused within the mouthpiece 50.

Some embodiments of the invention include using a liquid sensor so thatthe hydration material can be detected or the process can be stopped ifhydration is not detected. The liquid sensor can ensure delivery of thehydration material. Several different types of liquid sensors can beintegrated into the mouthpiece 10 (or 20, 30, 40, or 50), such as anelectrode, a polymer, a chemiresistor, a resonant circuit, atransmission line, or an (N)IR laser type sensor.

Some embodiments of the invention can include integrated syringes,sponges, capillaries, nanotubes, polymers, and/or wetting pull stripsfor purposes of hydrating the biosensor 11. Capillaries or nanotubes canbe used to collect moisture from the breath and deposit an appropriateamount on the active area of the biosensor 11. A wetting pull strip canbe an adhesive pull-back strip that, when pulled off, leaves moisture inthe mouthpiece 10.

Some embodiments of the invention include other sensors or components inorder to enhance functionality. The other sensors or components can beintegrated directly into the mouthpiece 10 as stand alone items, or canbe integrated into the mouthpiece 10 by means of a separate control unitthat is coupled electrically and/or mechanically to the mouthpiece 10.Some examples of other sensors include a gas flow sensor, a humiditysensor, a temperature sensor (such as stand-alone or printedthermocouple or thermoresistor), and a gas sensor (such as for oxygen orcarbon dioxide to determine alveolar air or breath composition). Sensorscan be stand-alone electrode-based sensors. Electrodes can be directlyintegrated into the mouthpiece 10 by screen or pad printing or platingand can include carbon, gold, platinum, palladium, or ruthenium, amongothers. Some examples of other components include a heater (such as aprinted resistive heater or ceramic heater placed near the active regionof the biosensor 11 to help control a chemical reaction taking place), avalve (such as a check valve or manual or automated shutoff valve toisolate the chamber of the mouthpiece 10 housing the biosensor 11), or abaffle (such as a disc or screen to modify the inlet 12 and/or outlet 13air flow).

It will be appreciated by those skilled in the art that while theinvention has been described above in connection with particularembodiments and examples, the invention is not necessarily so limited,and that numerous other embodiments, examples, uses, modifications anddepartures from the embodiments, examples and uses are intended to beencompassed by the claims attached hereto. The entire disclosure of eachpatent and publication cited herein is incorporated by reference, as ifeach such patent or publication were individually incorporated byreference herein. Various features and advantages of the invention areset forth in the following claims.

1. A mouthpiece for use with an electronic analyzer for breath analytedetection in an individual, the mouthpiece comprising: a biosensor thatdetects breath analytes, the biosensor including a chemically activearea where a chemical reaction takes place; a hydration system thatdelivers a liquid to the chemically active area of the biosensor to atleast one of enhance, enable, and facilitate the chemical reaction; andhardware that transmits breath analyte data to the electronic analyzer.2. The mouthpiece of claim 1 wherein the hydration system includes asack filled with the liquid and at least one of a syringe, a pin, and aroller to puncture the sack to deliver the liquid.
 3. The mouthpiece ofclaim 1 wherein the hydration system includes a pump assembly to deliverthe liquid.
 4. The mouthpiece of claim 3 wherein the pump assembly canbe coupled to the electronic analyzer.
 5. The mouthpiece of claim 1wherein the hydration system includes at least one of a syringe, asponge, a capillary tube, a nanotube, a polymer, and a wetting pullstrip.
 6. The mouthpiece of claim 1 wherein the hydration systemdelivers the liquid to the chemically active area by at least one ofdepositing the liquid directly above the chemically active area,depositing the liquid a distance away from the chemically active area,wherein capillary action brings the liquid to the chemically activearea, and depositing the liquid below the chemically active area,wherein wetting action brings the liquid to the chemically active area.7. The mouthpiece of claim 1 wherein the hydration system is manuallyactivated.
 8. The mouthpiece of claim 1 wherein the hydration system isautomatically activated.
 9. The mouthpiece of claim 1 wherein the liquidis at least one of water, an acid, a base, a hydrogel, a salt solution,and a neutral buffer.
 10. The mouthpiece of claim 1 wherein the liquidcontains polymers.
 11. The mouthpiece of claim 1 wherein a volume of theliquid is about 0.05 micro-liters to about 100 micro-liters.
 12. Themouthpiece of claim 1 wherein the viscosity of the liquid is about 0.1centipoise to about 200,000 centipoise.
 13. The mouthpiece of claim 1and further comprising a chamber housing the biosensor, an inletreceiving the individual's breath into the chamber, and an outletexhausting the individual's breath out of the chamber.
 14. Themouthpiece of claim 11 and further comprising a valve positioned in atleast one of the inlet and the outlet in order to isolate the chamber.15. The mouthpiece of claim 11 and further comprising a bafflepositioned in at least one of the inlet and the outlet in order tomodify flow of the individual's breath.
 16. The mouthpiece of claim 1and further comprising a heater positioned near the biosensor in orderto facilitate the chemical reaction.
 17. A breath analyte detectionsystem comprising: A mouthpiece including a biosensor capable ofdetecting breath analytes, the biosensor including a chemically activearea where a chemical reaction takes place; a hydration system providingliquid to the chemically active area of the biosensor to at least one ofenhance, enable, and facilitate the chemical reaction; hardware totransmit breath analyte data; and a portable electronic device capableof receiving the breath analyte data, the portable electronic devicecapable of at least one of storing, analyzing, and transmitting thebreath analyte data.
 18. A mouthpiece for use with an electronicanalyzer for analyte detection, the mouthpiece comprising: a biosensorincluding a chemically active area where a chemical reaction takesplace, the biosensor capable of detecting analytes in at least one ofbreath, saliva, urine, eye vapor, milk and blood; and a hydration systemproviding liquid to the chemically active area of the biosensor to atleast one of enhance, enable, and facilitate the chemical reaction. 19.A mouthpiece for use in breath analyte detection, the mouthpiececomprising: a biosensor capable of detecting breath analytes, thebiosensor including a chemically active area where a chemical reactiontakes place; a hydration system providing liquid to the chemicallyactive area of the biosensor to at least one of enhance, enable, andfacilitate the chemical reaction; an additional sensor capable ofdetecting additional parameters; and hardware to transmit breath analytedata and the additional parameters.
 20. The mouthpiece of claim 19wherein the additional sensor is at least one of a liquid sensor, a gasflow sensor, a humidity sensor, and a gas sensor.
 21. The mouthpiece ofclaim 19 wherein the additional sensor is an electrode-based sensor andcan be coupled to the mouthpiece via one of screen printing and padprinting.